A Phase I/II Study of the Toxic and Therapeutic Effects of T Cells in the Treatment of Epstein Barr Virus-Associated Lymphoproliferative Disorders

Protocol

95-024

Full Title

An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus (EBV)-Immune T-Lymphocytes Derived From Normal HLA-Compatible or Haplotype-Matched Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases or Malignancies and Patients with Detectable Circulating Levels of EBV DNA Who Are at High Risk for EBV-Associated Lymphoproliferative Diseases

Phase

I/II

Purpose

This study will evaluate a therapy for the treatment of a blood disorder caused by the Epstein-Barr Virus (EBV), the same virus that causes infectious mononucleosis. This blood disease, called EBV-lymphoproliferative disorder, occurs when a type of white blood cell, called a B cell, divides uncontrollably in the liver, lung, brain, or other vital organ. This disorder can be life threatening, and conventional cancer therapies often are not successful against it.

An EBV-lymphoproliferative disorder can develop in patients with weakened immune systems, such as those who have received bone marrow transplants or organ transplants. At Memorial Sloan-Kettering and at several other institutions, successful treatment of this disorder occurred in a small number of bone marrow transplant patients who received infusions of white blood cells taken from their bone marrow donors who were immune to Epstein-Barr virus. Based on these studies, Memorial Sloan-Kettering doctors want to learn whether donor white blood cells immune to EBV can be grown and treated in the laboratory to increase the number of EBV-immune cells and to reduce the number of cells that may react against a patient’s tissues (a process called graft-versus-host disease) or against a transplanted organ following a heart, lung, kidney, or liver transplant. Patients in the study will receive intravenous infusions of white blood cells, called T cells, which are immune to EBV.

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have weakened immune systems due to the immune suppression associated with a bone marrow or organ transplant or treatment of a cancer; or have a severe genetic deficiency of immunity, EBV-related lymphoma, or lymphoproliferative disease; or be at high risk for developing such a disorder.

Patients must have a genetically matched or half-matched relative who is immune to EBV and willing to donate T cells, or a genetically matched unrelated bone marrow donor who is immune to EBV.

For more information and to see if you or your child is eligible for this study, please contact Dr. Richard J. O’Reilly at 212-639-5957.